BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILVERHAWK LX-M PLAQUE EXCISION SYSTEM

    MDR report key: 1241261 · Received November 18, 2008

    Report

    Report Number
    2954936-2008-00065
    Event Type
    Injury
    Date Received
    November 18, 2008
    Date of Event
    October 30, 2008
    Report Date
    October 30, 2008
    Manufacturer
    FOX HOLLOW TECHNOLOGIES
    Product Code
    MCW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE SILVER-HAWK LX-M USED IN THE SFA AND POPLITEAL. PERFORATION OF TIBIAL PERONEAL TRUNK AFTER ATHERECTOMY WAS REPORTED. THREE PASSES MADE BEFORE DEVICE CAUGHT ON WHAT PHYSICIAN OBSERVED AS CALCIUM. PATIENT REQUIRED A SHORT SEGMENT OF SURGICAL BYPASS FROM THE SFA TO THE TIBIAL PERONEAL TRUNK. PATIENT CONDITION IS REPORTED AS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILVERHAWK LX-M PLAQUE EXCISION SYSTEM MCW FOX HOLLOW TECHNOLOGIES P4055 5941763

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention